A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolaas J Smit PhD, Medical Acoustics LLC
ClinicalTrials.gov Identifier:
NCT01186822
First received: August 19, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

This is a 26 week randomized controlled study. The study consists of, in order, an enrollment visit, followed by clinic visits at 2 weeks, 14 weeks and at 26 weeks. There will also be telephonic assessments at 8 weeks and 20 weeks. Clinic visits will involve comprehensive assessments of the patients lung condition, including post-bronchodilator spirometry, Shuttle walk distance, BODE index, health status (SGRQ) and symptoms (CCQ). Sputum and serum samples will also be collected at these visits for microbiological and inflammation analysis. Sputum will be obtained with the Lung Flute as an induction device and Pulse Oximetry will be assessed prior to and after use of the Lung Flute. Clinic and telephonic visits will collect information regarding compliance with the use of the Lung Flute, adverse events and exacerbation history.


Condition Intervention
COPD
Device: Lung Flute

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Six Month Randomized Controlled Clinical Trial of Lung Flute in Patients With Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:


Further study details as provided by Medical Acoustics LLC:

Primary Outcome Measures:
  • To evaluate the change in COPD symptoms assessed by the CCQ questionnaire between the intervention and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung Flute for BHT Device: Lung Flute
Used twice daily
No Intervention: No intervenstion

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects between and including the ages of 30 and 80 years. Females of childbearing potential may be included provided they are not pregnant or are not nursing.
  2. Subjects with a diagnosis of moderate to very severe chronic obstructive pulmonary disease as defined by the Global Initiative for COPD (GOLD, 2008 update) and who meet the following criteria for stage ll - IV disease:

    a) Subjects must have a post-bronchodilator FEV1/FEV ratio <70% and FEV1 of <80% of the predicted value for age, height, and sex using the NHANES III standards (Hankinson, 1999).

  3. Subjects must have a smoking history of at least 10 pack-years.
  4. Subjects must have stable disease for at least 1 month prior to enrollment with no changes in the maintenance treatment for COPD in this period.

    -

Exclusion Criteria:

  1. History of an exacerbation or other significant disease instability during the month preceding enrollment.
  2. A primary diagnosis of asthma or bronchiectasis.
  3. Inability to vibrate the reed of the Lung Flute® consistently because of severely expiratory flow rate.
  4. Subject with any evidence of significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct of the study or safety of the subject.
  5. Pregnant or nursing females or females intending to become pregnant during the course of the study.
  6. Use of any investigational drug within one month or 6 half-lives (which-ever is greater) of the enrollment visit.
  7. Inability to comprehend or willingness to follow the study requirements including attendance at out-patient clinic visit and participation in testing as called for by the protocol.
  8. Patients currently using the Lung Flute. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186822

Locations
United States, New York
VA WNY Healthcare System
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Nicolaas J Smit PhD
Investigators
Principal Investigator: Sanjay Sethi, MD VA WNY Healthcare System
  More Information

No publications provided

Responsible Party: Nicolaas J Smit PhD, Dr. S. Sethi, Medical Acoustics LLC
ClinicalTrials.gov Identifier: NCT01186822     History of Changes
Other Study ID Numbers: LF6mo
Study First Received: August 19, 2010
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014